Effectiveness of shared decision making strategies for stroke prevention among patients with atrial fibrillation: cluster randomized controlled trial

Abstract

Objective: To evaluate the effectiveness of multiple decision aid strategies in promoting high quality shared decision making for prevention of stroke in patients with non-valvular atrial fibrillation.

Design: Cluster randomized controlled trial.

Setting: Six academic medical centers in the United States.

Participants: Patient participants were aged ≥18 with a diagnosis of non-valvular atrial fibrillation, at risk for stroke (CHA₂DS₂-VASc ≥1 for men, ≥2 for women), and scheduled for a clinical appointment to discuss stroke prevention strategies. Participating clinicians were those who manage stroke prevention strategies for participating patients.

Intervention: Patients were randomized to use a patient decision aid or usual care; clinicians were randomized to use an encounter decision aid or usual care with all participating patients.

Main outcome measures: Primary outcome measures were quality of shared decision making measured by OPTION12, knowledge of atrial fibrillation and its management, and decisional conflict.

Results: 1117 participants across six sites were included in the analysis. Compared with usual care, the combined use of both the patient decision aid and the encounter decision aid improved the quality of shared decision making (adjusted mean difference 12.1 (95% confidence interval (CI) 8.0 to 16.2; P<0.001), improved patients' knowledge (odds ratio 1.68 (95% CI 1.35 to 2.09; P<0.001), and reduced patients' decisional conflict (adjusted mean difference -6.3 (95% CI -9.6 to -3.1; P<0.001). Statistically significant improvements were also observed with the encounter decision aid alone versus usual care for all three outcomes and with the patient decision aid alone versus usual care for quality of shared decision making and knowledge. No important differences were observed in treatment choices for stroke prevention or in participants' satisfaction. No statistically significant difference in the length of visit across study groups was detected.

Conclusion: Patients who received any decision aid (encounter decision aid, patient decision aid, or both) had lower decisional conflict, better shared decision making, and greater knowledge than those receiving no decision aid, except for the effect of the patient decision aid on decisional conflict, which did not reach statistical significance. The study establishes that use of either pre-visit or in-visit decision aids individually or in combination is advantageous compared with usual care.

Trial registration: ClinicalTrials.gov NCT04357288.

Fig 1

Screenshots of the patient decision aid (left) and encounter decision aid (right). These examples show how details of medication routine are described for each tool

Fig 2

CONSORT (Consolidated Standards of Reporting Trials) diagram. Patients were excluded after randomization for the following primary reasons: patient discovered to be ineligible (eg, no diagnosis of atrial fibrillation, contraindication to oral anticoagulants), missed or cancelled appointments, patient withdrew from study. EDA=encounter decision aid; PDA=patient decision aid

Fig 3

Subgroup analyses for primary comparisons between encounter decision aid (EDA) and patient decision aid (PDA) versus control. Mean difference and 95% confidence interval (CI) for both EDA and PDA versus control group are presented for OPTION12 and Decisional Conflict Score (DCS). Odds ratio and 95% CI for both EDA and PDA versus control group are presented for knowledge. *P value for comparison between subgroups